Lead Biologics Quality Assurance Director

1 week ago

Miami, United States Summittherapeutics Full time
Job Description

We are seeking a seasoned Director of Quality Assurance to lead our biologics quality assurance efforts at Summit Therapeutics.

Key Responsibilities:

  • Develop and implement robust quality systems, including policies and procedures, to ensure compliance with global health authority regulations and industry standards.
  • Provide sponsor oversight of Contract Manufacturing Organizations (CMOs) for clinical and commercial manufacture.
  • Oversight of GXP compliance for all vendors and CMOs, with on-site visits as needed.
  • Ensure inspection readiness for Summit and external CMOs.
  • Establish internal QA batch review and release processes for batch disposition of drug products.
  • Supervise internal audits of departments and processes.
  • Review and develop policies to ensure compliance with regulations.
  • Write, revise, and approve SOPs and controlled documents.
  • Cross-functional collaboration and alignment with other departments to achieve quality objectives.
  • Develop a robust quality system and foster best practices across the organization.
  • Ensure timely resolution of issues and delivery of results.
  • Establish performance metrics.

Requirements:

  • Bachelor's degree in chemistry, biochemistry, biotechnology, or related life sciences discipline. A higher degree is preferred.
  • Minimum 10+ years of relevant experience, preferably with GMP manufacturing requirements for clinical and commercial biologics.
  • Demonstrated expertise in managing CMOs, designing quality systems, and risk management tools.
  • Experience leading inspections and managing complex business relationships with QPs.
  • Excellent communication skills, fluency in Mandarin is highly preferred.
  • Ability to work independently in a fast-paced environment with multiple priorities.
  • Attention to detail, accuracy, and thoroughness expected in all aspects of work.
  • Strong work ethic, excellent interpersonal skills, and collaboration.

Estimated Salary: $140,000 - $180,000 per year, depending on location and qualifications.

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